Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorJiangxi Qingfeng Pharmaceutical Co. Ltd.

About this trial

The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined with antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease.The secondary objectives is to evaluate the effect of Xiyanping injection on the indicators of acute exacerbation of inflammation and symptom improvement of chronic obstructive pulmonary disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Discharged with chronic obstructive pulmonary disease;

Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;

The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;

Study patients with complete medical records.

Disqualifiers

Researchers believe that multiple proprietary Chinese medicines with the same or similar functions (such as Tanreqing injection, Reduning injection, Yanhuning injection, etc.) have been used at the same time during treatment, resulting in no assessment of efficacy or safety;

Patients with viral pneumonia or other systemic infection (such as urinary tract infection);

Patients who do not use intravenous antibiotics;

Refuse the case to be used by researchers.

Trial population

Patients with acute exacerbation of chronic obstructive pulmonary disease

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Xiyanping injection+ antibiotic

    Drug

    Xiyanping injection+ antibiotic

  • Antibiotic

    Drug

    Antibiotic

Treatment groups

1,140 Participants
are divided into 2 treatment groups
Group A: Exposure group1 intervention
Group B: Non-exposure group1 intervention

Trial outcomes

Primary outcomes

1

Course of intravenous antibiotics

Duration of intravenous antibiotic use

Time frame
baseline, at 3(±1), 7(±1), and 10 days during medication

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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